Main Points of "Proposals for New Systems to Prevent Harmful Effects From Pharmaceutical and Bio-Chemical Products"
The Study Group on Systems for Preventing Harmful Effects from
Pharmaceutical and Bio-Chemical Products
1. The Purpose of This Research
To analyze the structural factors which resulted in harmful effects caused by pharmaceutical and bio-chemical products and to propose measures, based on safety and scientific knowledge, to ensure that such cases never occur again.
2. Analyses and information on which proposals are based
(1) Analysis of the structural factors which resulted in harmful effects caused by pharmaceutical and bio-chemical products. The factors in organizational structure outlined below should be countered by the following points.
1) Closed relationship among industry, bureaucracy, academia and medical care professionals
(2) Safety and scientific knowledge
-->Patient-oriented medical treatment
2) Patriarchal relationship between the government and citizens
-->The principle of personal choice and responsibility for the citizenry
3) Low level of medicine and medical care
-->Catch-up with the world standard
4) Administration of regulations and coordination
-->Administration of information dissemination and risk management
Establishment of a risk management system of pharmaceutical products (multiple protective measures)3. Proposals: 9 points
(1) Promptly establish a risk management system to prevent harmful effects caused by pharmaceutical and bio-chemical products
1) Clarify the responsibility and duty of industry, bureaucracy, academia and medical care professionals.
(2) Make the establishment of patient-oriented medical treatment the core of any new policy2) Review the remuneration system of medical staff providing medical examinations and treatment and shift to a more technology-centered system.
1) Establishment of a "Patients' Rights Act"
(3) Revise the current relationship among industry, bureaucracy, academia and medical care professionals2) Adopt informed consent regulations
3) Make clinical charts the property of the patients
1) End the existing cozy relationship among these four entities (prohibition of amakudari, in which retired bureaucrats are often given cushy jobs in industries they formerly regulated)
(4) Roles to be played by the Ministry of Health and Welfare2) Make all roles and relations in these interrelating fields transparent
3) Establish a collaborative relationship
1) Create visions for the future
(5) Reinforcement of information dissemination2) Deal with the national crisis
1) Establish a system to actively disseminate information
(6) Implementation of a strict and scientific inspection system for medical and pharmaceutical products2) Clarify who is responsible
3) Accountability
1) Conduct an inspection of newly developed products based on the world standard
(7) Review the prices of medicine and introduce a strict responsibility system for doctors2) Shift responsibility for inspection from the Ministry of Health and Welfare to a private inspection organization
3) Introduce a trial use period system
4) Require each pharmaceutical and bio-chemical product to carry "insurance against harmful effects"
5) Clarify responsibility of pharmaceutical companies' management
1) Establishment of standard measures of medical treatment
(8) Ensure the safety of blood products2) Utilization of informed consent
3) Clarify the responsibility of doctors and introduce a strict responsibility system
1) Proper use of blood products
(9) Early implementation of relief measures for medical-related suffering2) Disseminate information about the blood product business and clarify the role of the Japanese Red Cross Society
3) Devise systems to provide relief to victims
1) Introduction of a system to demand compensation by proxy
2) Improve the efficiency of the current compensation provision system
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